Facility

ASO AMERICAS, S. de R. L. de C. V.

7 recall(s) on record — most severe on record: Class II.

Key facts

7recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3005761322
Establishment type	Repack or Relabel Medical Device
Location	CENTRO INDUSTRIAL JUAREZ, JUAREZ Chihuahua, MX 32648
Registration status	Active · expires 2026
Parent company	ASO LLC (owner-operator 1038758)

Activity by year

Recalls (7)

Devices registered here (1)

Vinyl Patient Examination Glove
Product code LYZ (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6250

Recalls & enforcement

Class IIOngoing2023-03-23
The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling.
Class IIOngoing2022-06-22
The product falls apart during handling after removal from its primary packaging.
Class IITerminated2022-03-02
Kits contained recalled acetaminophen.
Class IIOngoing2018-10-16
Potential that gauze pads may not be fully sterilized
Class IITerminated2015-06-10
Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed as an active ingredient in the product label.
Class IITerminated2013-08-21
No antibacterial bandages were packed in boxes labeled as antibacterial.
Class IITerminated2013-07-26
This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ASO AMERICAS, S. de R. L. de C. V. (FEI 3005761322) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005761322-aso-americas-s-de-r-l-de-c-v/

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